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FDA 510(k)

OmniTrans Transport System

K-Number: K240235 · 2024-08-19

ApplicantShenzhen Dakewe Bio-Engineering Co., Ltd.
Decision Date2024-08-19
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OmniTrans Transport System is a medical device manufactured by Shenzhen Dakewe Bio-Engineering Co., Ltd.. It received FDA 510(k) clearance on 2024-08-19 under approval number K240235. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OmniTrans Transport System?

OmniTrans Transport System is a medical device that received FDA 510(k) clearance on 2024-08-19. It is manufactured by Shenzhen Dakewe Bio-Engineering Co., Ltd.. The 510(k) number is K240235.

When was OmniTrans Transport System approved by the FDA?

OmniTrans Transport System received FDA 510(k) clearance on 2024-08-19, under approval number K240235.

What company makes OmniTrans Transport System?

OmniTrans Transport System is manufactured by Shenzhen Dakewe Bio-Engineering Co., Ltd..

What is the FDA product code for OmniTrans Transport System?

The FDA product code for OmniTrans Transport System is JSM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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